NCT01149421

Brief Summary

The purpose of this study is to assess the effects of 2 doses of LY2189265 on blood pressure and heart rate using 24-hour ambulatory blood pressure monitoring (ABPM), in participants with type 2 diabetes mellitus treated with oral antihyperglycemic medications (OAMs).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
755

participants targeted

Target at P75+ for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2010

Typical duration for phase_2 diabetes-mellitus-type-2

Geographic Reach
8 countries

76 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

February 2, 2015

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

1.3 years

First QC Date

June 15, 2010

Results QC Date

October 3, 2014

Last Update Submit

January 29, 2015

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 DiabetesDiabetesAmbulatory Blood Pressure MonitoringABPMBlood PressureHeart Rate

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)

    Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.

    Baseline, 16 weeks

Secondary Outcomes (24)

  • Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)

    Baseline, 26 weeks

  • Change From Baseline to 16 and 26 Weeks in Mean 24-hour Diastolic Blood Pressure (DBP)

    Baseline, 16 and 26 weeks

  • Change From Baseline to 16 and 26 Weeks in Mean 24-Hour Heart Rate (HR)

    Baseline, 16 and 26 weeks

  • Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressure

    Baseline, 16 and 26 weeks

  • Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP)

    Baseline, 16 and 26 weeks

  • +19 more secondary outcomes

Study Arms (3)

1.5 milligram (mg) LY2189265

EXPERIMENTAL

LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW)

Drug: LY2189265

0.75 milligram (mg) LY2189265

EXPERIMENTAL

LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW)

Drug: LY2189265

Placebo

PLACEBO COMPARATOR

Placebo: subcutaneous (SC), once weekly (QW)

Drug: Placebo

Interventions

LY2189265DRUG

Administered as a subcutaneous injection once weekly for 26 weeks

Also known as: Dulaglutide
0.75 milligram (mg) LY21892651.5 milligram (mg) LY2189265
PlaceboDRUG

Administered as a subcutaneous injection once weekly for 26 weeks

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes taking 1 or more oral diabetes medications and have taken these medications for at least 1 month prior to screening
  • Glycosylated hemoglobin (HbA1c) value ≥7% and ≤9.5% at screening
  • Mean blood pressure \>90/60 millimeters of mercury (mmHg) and \<140/90 mmHg at screening
  • If treated for hypertension, are taking 3 or less antihypertensive medications and have been taking these medications for at least 1 month prior to screening
  • Stable weight for 3 months prior to screening
  • Body mass index (BMI) greater than or equal to 23 kilogram-meter squared (kg/m\^2)
  • Willing to wear an ambulatory blood pressure monitoring device for at least 24 hours on multiple occasions
  • Women of childbearing potential must test negative for pregnancy and be willing to use a reliable method of birth control
  • Male participants must use a reliable method of birth control

You may not qualify if:

  • Myocardial infarction, stroke, or hospitalization for heart failure within 3 months prior to screening, or heart failure Class III or IV at screening
  • Ongoing or history of frequent intermittent tachyarrhythmia
  • Resting heart rate \<60 beats per minute (bpm) or \>100 bpm at screening
  • Work rotating shifts or work during the hours of 2200 to 0700
  • Chronic insulin therapy
  • Use of a glucagon-like peptide 1 (GLP-1) receptor agonist within 3 months prior to screening, or a dipeptidylpeptidase-IV (DPP-IV) inhibitor within 2 weeks prior to screening
  • Nondominant arm circumference \>42 centimeter (cm)
  • Use of drugs to promote weight loss
  • Chronic use of systemic steroids
  • Gastric emptying abnormality or bariatric surgery
  • Hepatitis, other liver disease, or alanine transaminase (ALT) \>3 times the upper limit of normal
  • Acute or chronic pancreatitis
  • Severe renal impairment
  • Active autoimmune disease or uncontrolled endocrine abnormality
  • Self or family history of thyroid cancer, medullary C-cell hyperplasia, or type 2A or 2B multiple endocrine neoplasia
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (76)

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Phoenix, Arizona, 85013, United States

Location

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Anaheim, California, 92801, United States

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Greenbrae, California, 94904, United States

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Lancaster, California, 93534, United States

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Los Angeles, California, 90057, United States

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Sacramento, California, 95825, United States

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Spring Valley, California, 91978, United States

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Coral Gables, Florida, 33134, United States

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Daytona Beach, Florida, 32114, United States

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Orlando, Florida, 32806, United States

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Tampa, Florida, 33613, United States

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Winter Haven, Florida, 33880, United States

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Cartersville, Georgia, 30121, United States

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Gainesville, Georgia, 30501, United States

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Tucker, Georgia, 30084, United States

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Honolulu, Hawaii, 96814, United States

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Idaho Falls, Idaho, 83404, United States

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Bloomington, Indiana, 47403, United States

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Indianapolis, Indiana, 46260, United States

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Louisville, Kentucky, 40217, United States

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Paducah, Kentucky, 42001, United States

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Metairie, Louisiana, 70006, United States

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Auburn, Maine, 04210, United States

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Columbia, Maryland, 21045, United States

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Haverhill, Massachusetts, 01830, United States

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Springfield, Massachusetts, 01199, United States

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Detroit, Michigan, 48201, United States

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Jackson, Mississippi, 39216, United States

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Jefferson City, Missouri, 65109, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68124, United States

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Albuquerque, New Mexico, 87106, United States

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Garden City, New York, 11530, United States

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Dayton, Ohio, 45439, United States

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Jefferson Hills, Pennsylvania, 15022, United States

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Johnstown, Pennsylvania, 15905, United States

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Austin, Texas, 78728, United States

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Georgetown, Texas, 78626, United States

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Houston, Texas, 77034, United States

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Salt Lake City, Utah, 84124, United States

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Renton, Washington, 98057, United States

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Vancouver, Washington, 98664, United States

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Buenos Aires, 1657, Argentina

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Caba, C1050AAK, Argentina

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Mar del Plata, B7600FZN, Argentina

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Mendoza, 5500, Argentina

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Santa Fe, 3000, Argentina

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Rio de Janeiro, 22271-100, Brazil

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São Paulo, 04020-041, Brazil

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Calgary, Alberta, T2H 2G4, Canada

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Red Deer, Alberta, T4N 6V7, Canada

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Vancouver, British Columbia, V6H 3X8, Canada

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Victoria, British Columbia, V8V 3N7, Canada

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Winnipeg, Manitoba, R3P 3P4, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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Hamilton, Ontario, L8L 2X2, Canada

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Oakville, Ontario, L6H 3P1, Canada

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Toronto, Ontario, M4G 3E8, Canada

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Laval, Quebec, H7T 2P5, Canada

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Saint-Laurent, Quebec, H4T 1Z9, Canada

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České Budějovice, 370 01, Czechia

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Český Krumlov, 381 01, Czechia

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Prague, 181 00, Czechia

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Přerov, 750 02, Czechia

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Aalborg, 9000, Denmark

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Ballerup Municipality, 2750, Denmark

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Vejle, 7100, Denmark

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Ahmedabad, 380006, India

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Coimbatore, 641009, India

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Indore, 452002, India

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Jaipur, 302001, India

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Ludhiana, 141001, India

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Ponce, 00717-2075, Puerto Rico

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Rio Piedras, 00921, Puerto Rico

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San Juan, 00917-3104, Puerto Rico

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Santurce, 00909, Puerto Rico

Location

Related Publications (1)

  • Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.

    PMID: 36894938DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2010

First Posted

June 23, 2010

Study Start

June 1, 2010

Primary Completion

September 1, 2011

Study Completion

January 1, 2012

Last Updated

February 2, 2015

Results First Posted

February 2, 2015

Record last verified: 2015-01

Locations

CA(11)US(42)CZ(4)DK(3)IN(5)AR(5)PR(4)BR(2)